AB0904 Evaluating Numeric Rating Scale Versions of the 3 and 4 Visual Analog Scale (3/4-VAS) Composite Measures in Patients with Active Psoriatic Arthritis from the SELECT-PsA Program
Authors: W. Tillett, L. Coates, M. Kishimoto, A. Setty, T. Gao, R. Lippe, P. Helliwell
Journal: Annals of the Rheumatic Diseases (2022)

Background The multifaceted nature of psoriatic arthritis (PsA) can make it challenging to evaluate treatment targets and disease activity. Moreover, most existing assessment tools are time-consuming and not always feasible in routine clinical care, indicating a need for new disease measures that are easy to perform and calculate. Composite measures using 3-visual analog scale (VAS; physician’s global assessment, patient’s global assessment, and skin) or 4-VAS (physician’s global assessment, joints, skin, and pain) have been proposed as simpler alternatives. 1 Given potential advantages of numeric rating scales (NRS) over VAS, we here adapted 3/4-VAS for use with NRS components and tested its validity via post hoc analysis of the upadacitinib (UPA) SELECT-PsA program. Objectives Evaluate the ability of 3/4-NRS scores to assess treatment response in SELECT-PsA 1 and 2, as well as the correlation of 3/4-NRS with other common disease activity measures. Methods Data are from the SELECT-PsA 1 and 2 phase 3 trials in patients with prior inadequate response or intolerance to ≥1 non-biologic DMARD or ≥1 biologic DMARD, respectively. In both trials, patients received once daily UPA 15 mg, UPA 30 mg, or placebo (PBO); SELECT-PsA 1 also included the active comparator adalimumab (ADA) 40 mg every other week (wk). 3-NRS scores were determined using the mean of SAPS questions 1–10, physician’s global assessment of disease activity, and patient’s global assessment of disease activity; 4-NRS scores were determined using the mean of SAPS questions 1–10, physician’s global assessment of disease activity, patient’s assessment of pain, and BASDAI question 3 related to joint pain and swelling. The 3/4-NRS scale ranges from 0 (no disease activity) to 10 (severe activity). 3/4-NRS and cDAPSA (DAPSA without the CRP component) were assessed at all available visits through wk 56. Correlations between 3/4-NRS with PsA disease activity score (PASDAS), routine assessment of patient index data 3 (RAPID3), DAPSA, cDAPSA, and other disease activity measures were determined by nonparametric Spearman rank correlation coefficient for UPA 15 mg patients from both trials and ADA for SELECT-PsA 1. All data are shown as observed; nominal p-values are provided throughout. Results A total of 1281 and 423 patients were included from SELECT-PsA 1 and 2, respectively. For both cDAPSA and 3/4-NRS scores, patients receiving UPA 15 mg showed clear numerical improvements compared with PBO at wk 24 in both trials (Table 1). 3/4-NRS scores were highly correlated with RAPID3 and PASDAS measures (r &gt;0.6, P &lt;0.0001) for UPA 15 mg patients at baseline (Figure 1). Moderate correlations were observed between 3/4-NRS and DAPSA/cDAPSA (r = ~0.4, P &lt;0.0001), as well as physical function (HAQ-DI) and quality of life measures (SF-36). Nominally significant but weaker correlations were detected for joints, skin, and other disease activity assessments. Similar overall results were observed for patients receiving ADA. Table 1. 3/4-NRS and cDAPSA Disease Activity Scores at Week 24 and 56 (As Observed ) SELECT-PsA 1 Wk 24 Wk 56 Mean score [n] PBO UPA 15 mg ADA UPA 15 mg ADA 3-NRS 3.7 [370] 2.2 [398] 2.4 [398] 1.8 [372] 2.0 [359] 4-NRS 3.8 [367] 2.3 [392] 2.6 [395] 1.9 [367] 2.2 [357] cDAPSA 24.0 [372] 14.9 [399] 16.6 [400] 10.2 [372] 11.3 [358] SELECT-PsA 2 Wk 24 Wk 56 Mean score [n] PBO UPA 15 mg UPA 15 mg 3-NRS 4.7 [172] 2.9 [190] 2.4 [164] 4-NRS 4.9 [170] 3.1 [188] 2.7 [162] cDAPSA 37.1 [172] 21.6 [190] 15.3 [166] 3/4-NRS ranges from 0–10; cDAPSA ranges from 0–154. Lower scores indicate decreased disease activity. Conclusion 3/4-NRS was able to successfully discriminate between PBO and therapeutic groups in SELECT-PsA 1 and 2. 3/4-NRS scores correlated well with other clinical and patient reported outcome measures, including those focused on joints (DAPSA) or multiple manifestations (PASDAS), supporting 3/4-NRS as a viable and easy to use tool in daily clinical practice. References [1]Tillett W, et al. J Rheumatol 2021; 201675. Acknowledgements AbbVie and the authors thank the patients, study sites, and investigators who participated in these clinical trials. AbbVie funded these studies and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Matthew Eckwahl, PhD, of AbbVie. Disclosure of Interests William Tillett Speakers bureau: AbbVie, Amgen, Celgene, Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Celgene, Lilly, Janssen, MSD, Novartis, Pfizer, and UCB., Laura Coates Speakers bureau: AbbVie, Amgen, Biogen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, GSK, Janssen, Lilly, Medac, Novartis, Pfizer, Serac, and UCB., Consultant of: AbbVie, Amgen, Biogen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, GSK, Janssen, Lilly, Medac, Novartis, Pfizer, Serac, and UCB., Mitsumasa Kishimoto Consultant of: AbbVie, Amgen-Astellas BioPharma, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Celgene, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Kyowa Kirin, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, Teijin Pharma, and UCB Pharma., Arathi Setty Shareholder of: AbbVie, Employee of: AbbVie, Tianming Gao Shareholder of: AbbVie, Employee of: AbbVie, Ralph Lippe Shareholder of: AbbVie, Employee of: AbbVie, Philip Helliwell Paid instructor for: Educational services: Abbvie, Amgen, Novartis, Janssen, Consultant of: Eli Lilly